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Office for Human Research Protections (OHRP)

The Department of Health and Human Services
Meeting of the
Secretary's Advisory Committee on Human Research Protections (SACHRP)

Monday, March 29 & Tuesday, March 30, 2004
Holiday Inn Hotel and Suites
Commonwealth Center
625 First Street
Alexandria, Virginia

DRAFT AGENDA

Monday, March 29, 2004

8:30 a.m. - 8:35 a.m.

Welcome: Opening Remarks
Ernest Prentice, Ph.D.
Chairman, SACHRP

8:35 a.m. - 8:45 a.m.

Report on Issues
Bernard A. Schwetz, D.V.M., Ph.D.
Acting Director, OHRP

8:45 a.m. - 9:00 a.m.

Overview of Charges to Subcommittees
Ernest Prentice, Ph.D.

9:00 a.m. - 10:30 a.m.

Subpart D Subcommittee Report/Issues

10:30 a.m. - 10:45 a.m.

BREAK

10:45 a.m. - 11:45 p.m.

Subpart D Subcommittee Report/Issues...Cont.

11:45 p.m. - 12:45 p.m.

LUNCH

12:45 p.m. - 2:45 p.m.

Subpart C Subcommittee Report/Issues

2:45 p.m. - 3:00 p.m.

BREAK

3:00 p.m. - 3:45 p.m.

Accreditation Subcommittee Report

3:45 p.m. - 4:30 p.m.

Public Comment

4:30 p.m. - 5:00 p.m.

Summary of Day's Activities
Ernest Prentice, Ph.D.



Tuesday, March 30, 2004

8:30 a.m. - 8:45 a.m.

Additional Business
Ernest Prentice, Ph.D.
Chairman, SACHRP

8:45 a.m. - 9:45 a.m.

Litigation Issues Presentations
Haavi Morreim, Ph.D.
Department of Human Values and Ethics
University of Tennessee College of Medicine

9:45 a.m. - 10:00 a.m.

BREAK

10:00 a.m. - 12:00 p.m.

HIPAA Privacy Rule Panel
Susan McAndrew, Office of Civil Rights,
  Department of Health and Human Services
Susan Ehringhaus, Associate General Counsel for
  Regulatory Affairs, Association of American
  Medical Colleges
Mark Rothstein, Director
  Institute for Bioethics, Health Policy and Law
Joanne Pollak, Vice President and
  General Counsel, John Hopkins Medicine

12:00 p.m. - 1:00 p.m.

LUNCH

1:00 p.m. - 1:30 p.m.

Adverse Event Reporting Issues Review/Discussion
Ernest Prentice, Ph.D.

1:30 p.m. - 2:00 p.m.

International Issues Review/Discussion
Dr. Mary Lake Polan

2:00 p.m. - 3:00 p.m.

Public Comment

3:00 p.m. - 3:15 p.m.

BREAK

3:15 p.m. - 4:00 p.m.

Future Business Issues, Including Discussion on:
     Subpart B
     Conflict of Interest
     Decisionally Impaired Subjects

4:00 p.m.

ADJOURN



Last revised: June 18, 2004

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